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Senior Director, Drug Safety Operations and Compliance
3 months ago
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.
When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to
Position Summary:
The Senior Director, Safety Operations and Compliance will serve as a safety expert accountable for the oversees planning, implementation, and management of Safety Operations and Compliance activities in support of the Ideaya Biosciences development portfolio, in close collaboration with other Safety and Medical staff.
This individual must be able to work effectively in a matrix, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies.
This position will report to the Vice President of Pharmacovigilance and Patient Safety.
This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
What you'll do:
- Responsible for the strategic planning, implementation, and management of Ideaya Safety Operations activities
- Responsible for leading, supporting, and managing the relationships with the safety vendor(s) to ensure effectiveness, quality, and compliance of outsourced activities
- Ensures timely submission of expedited safety reports to Regulatory Authorities in conjunction with the safety vendor, clinical CROs, and Regulatory Operations
- Responsible for safety management plans, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow between CROs, and Ideaya are clearly delineated and followed
- Management of safety staff both full time and contract
- Develop a good cross functional relationship with clinical, data management, regulatory, clinical operations, quality, medical writing, legal and finance
- Make sure the safety remains within the allocated budget for the fiscal year and also provide projected budget every six months
- Responsible for the development and maintenance of Safety Data Exchange Agreements with Ideaya' s partners and ensures compliance with the agreed upon terms
- Reviews the safety sections of clinical documents, including the safety reporting section of protocols
- Responsible for the development, implementation, and maintenance a Safety quality management system including the identification and authoring of required procedural documents to ensure compliance with global regulations
- Responsible for the development of internal and external (with vendors) key performance indicators and metrics to track performance Serves as the Safety subject matter expert for internal audits and global inspections
- Working knowledge of safety database (ARGUS) and managing all the workflows and experience in database configuration for new studies
- Working knowledge of data listing outputs form ARGUS for risk assessment, aggregate reporting's for DSUR
- Experience in managing SAE narrative writing with safety MD's
- Work with safety scientists and safety MDs to prepare for executive safety advisory committee meetings
- Support safety data needed for investigator brochure and DSUR
- Work with safety scientist, safety MD and data management to ensure that all the data is available from EDC for risk assessment
- Maintain safety regulatory calendar for all period submissions
- Work with IT to have safety icon on the intranet and structure a safety file folder for all safety related outputs which follows global regulations
- Responsible for identifying and following-up on corrective action plans arising from audits and inspections
- Responsible for safety inspection readiness activities and preparation and works in collaboration with GCP Quality to align on scheduling of audits for safety vendors
- Collaborates with Clinical Quality to ensure awareness and training of appropriate Ideaya personnel to Safety specific policies and SOPs as appropriate
- Make sure that all global SOPs are written to maintain compliance with global regulations and partner audits
- Responsible for hiring and providing managerial support to direct reports with overall responsibility of leading, training, and mentoring for effective performance
- Effectively collaborates with key stakeholders of cross-functional departments to meet corporate and departmental goals
Requirements:
- Master's degree, PharmD, RN in Life Sciences, with10 years' experience in Pharmacovigilance. Oncology experience preferred Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams
- Ability to establish and identify best practices for continuous improvement of case quality, compliance, and process improvement
- Demonstrates the ability to handle increasing responsibilities as scope may change relate to team growth and integration efforts cross-functionally
- Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with cross-functional colleagues
- Ability to work independently, establish priorities, and execute with minimal guidance
- Thorough knowledge and experience in safety reporting in both the clinical trial and post-market settings
- Strong knowledge and experience with available drug safety database systems, document management systems, and QC tools
- Extensive experience participating in inspections/audits and leading efforts around related CAPAs
- Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
- Expert knowledge of global safety regulations and guidelines Excellent interpersonal, communication, analytical, and organizational skills Strong computer skills desirable, particularly
- Power Point preparations Strong and positive people and project management experience
- Experience with auditing/planning audits
The salary range is an estimate and may vary based on the Company's compensation practices.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Benefits
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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